Servier Pharmaceuticals
Paris and Boston, March 15, 2023 (Reuters) /PRNewswire/
- Clinically meaningful achievement of primary and secondary endpoints is the first major advance in the treatment of low-grade glioma in more than 20 years
- Endpoints achieved in a predefined interim analysis
- Vorasidenib Receives Accelerated Approval Status from the U.S. Food and Drug Administration (FDA)
Dienst, a global pharmaceutical company, announced today that the Phase 3 INDIGO trial evaluating vorasidenib as monotherapy in patients with residual or recurrent IDH-mutated low-grade glioma met its primary endpoint of progression-free survival (PFS) and met the key secondary endpoint of time to next intervention (TTNI). The results of the predefined interim analysis were both statistically and clinically significant.
“The therapeutic progress in the field of low-grade gliomas has stagnated for decades. The results of the phase 3 INDIGO study, in which both the primary endpoint of progression-free survival and the important secondary endpoint of time to the next intervention were met, make it possible to transform the treatment model for patients with IDH-mutated low-grade glioma, by potentially delivering the first targeted therapy,” said Susan Pandya, MD, Associate Director, Clinical Development and Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Dienst. “We We are deeply indebted to the patients, caregivers, researchers and study teams who made this remarkable achievement possible through their participation in the INDIGO clinical trial.”
The interim analysis provided in the draft INDIGO study showed a statistically significant and clinically meaningful improvement in both progression-free survival and time to the next intervention in the patients randomized to receive vorasidenib monotherapy compared to those Patients who received a placebo. Patients enrolled in the INDIGO study had residual or recurrent Grade 2 oligodendroglioma or astrocytoma with an IDH-1 or IDH-2 mutation and had undergone surgery as the only treatment for their glioma prior to enrollment in the study. The safety profile of vorasidenib monotherapy was consistent with previously published data.
“This potential therapeutic breakthrough is another concrete demonstration of the success of our oncology strategy, which aims to focus our science on difficult and difficult-to-treat cancers, such as those harboring an IDH mutation,” said Dr. Patrick Therasse , Vice President and Chair of Late-Phase and Life-Cycle Oncology and Immuno-Oncology Therapeutic Area, Dienst, “Results from the Phase 3 INDIGO study offer potential hope for patients with IDH-mutated low-grade glioma for the first time in more than 20 years a new treatment option.”
Results from the phase 3 INDIGO trial will be presented at an upcoming medical meeting.
Due to accelerated patient enrollment and interim efficacy analysis results, the INDIGO clinical trial is well ahead of schedule. Dienst is working to determine application submission deadlines and adjust supply capacities for vorasidenib.
About the Phase 3 INDIGO study
INDIGO is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who underwent surgery as the only treatment . (NCT04164901).
Information on Gliomas1 Gliomas are tumors that arise from glial or progenitor cells in the central nervous system (CNS). The 2021 WHO classification distinguishes four general groups of gliomas, which include adult-type diffuse gliomas. These diffuse gliomas are the most common primary malignant brain tumors in adults. Pathogenesis and prognosis of these tumors are closely linked to mutations (or lack thereof) in the metabolic enzyme isocitrate dehydrogenase (IDH), and molecular testing is required for a correct diagnosis. As of 2021, adult-type diffuse gliomas are divided into only three categories:
- Astrocytoma, IDH mutated (CNS WHO grades 2-4)
- Oligodendroglioma IDH-mutated, 1p19q code-deleted (CNS WHO grade 2-3)
- Glioblastom IDH-Wildtyp (ZNS WHO-Grad 4)
1 neuro-oncology. The 2021 WHO classification for tumors of the central nervous system: a summary. Last accessed – 03/13/23
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About Serving
About Dienst in the United States
Disclosures
Media contact:
Eric Fohlen-Weill [email protected]
Nathan Mellor [email protected]
Founded to serve health, Dienst is a global pharmaceutical company governed by a foundation dedicated to making a meaningful social impact on both patients and a sustainable world. With its unique leadership model, it fully lives up to its vocation with a long-term vision: a commitment to therapeutic advancement to meet patient needs. The group’s 21,400 employees are committed to this common vocation, which is a source of inspiration every day.
As a global leader in cardiology, Dienst’s goal is to become a respected, focused and innovative partner in oncology, focusing on challenging and intractable cancers. Therefore, the group allocates more than 50% of its R&D budget to oncology.
Neuroscience and inflammatory diseases of the immune system are the growth drivers of the future. In these areas, Dienst focuses on a limited number of diseases where accurate patient profiling allows for a targeted therapeutic response through precision medicine.
To promote access to quality care at lower cost, the group also offers a range of high quality generic medicines for most medical conditions, relying on strong brands in France, Eastern Europe, Brazil and Nigeria.
In all of these areas, the group involves patients at every stage of a medicine’s life cycle.
Dienst is headquartered in France and has a strong geographic presence in more than 150 countries. In 2022, the company achieved sales of 4.9 billion euros.
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As a leader in oncology, Dienst is committed to finding solutions that meet today’s challenges. The company’s oncology portfolio includes innovative medicines designed to bring more life-saving treatments to more patients across the disease spectrum and across a variety of tumor types. Dienst has significantly increased its investments in difficult and hard-to-treat cancers. More than 50% of research and development work is aimed at making significant advances in areas that could mean real progress for our patients.
Dienst believes that co-creating innovation is an essential enabler to drive innovation and actively builds alliances, licensing agreements and partnerships that deliver solutions and accelerate access to therapies. With its commercial savvy, global reach, scientific expertise and commitment to clinical excellence, Dienst is committed to bringing the promise of a better future to the patients we serve in the United States.
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